FDA Inspection
Steriscience SP. Z O.O.Steriscience SP. Z O.O. – FDA Inspection, Apr 28, 2023
Record Details
This FDA Inspection record concerns Steriscience SP. Z O.O., with an inspection on April 28, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e5aab524-e15b-486e-a8a8-76a755600e6b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1203774
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.25(a)Training , Education , Experience overall
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Other FDA inspections of Steriscience SP. Z O.O.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 14, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 13, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Steriscience SP. Z O.O.
- FDA Inspection 866277 - 2014-02-14
- FDA Inspection 800716 - 2012-09-13
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